The Effect of Synching Prescription Refills on Adherence | NCT01934608

Studies
The Effect of Synching Prescription Refills on Adherence

NCT01934608

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Dec 22, 2015Estimated

Enrollment

691Actual

Phase

Not Applicable

Conditions

Hypertension
Hypercholesterolemia
Diabetes
Medication Adherence

Interventions

Refill synch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Aug 29, 2013

First Submission Date that Met QC Criteria

Aug 29, 2013

First Posted Date

Sep 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2015

Last Update Posted Date

Dec 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the effect of synchronizing a patient's prescription refill schedule on medication adherence. The targeted population is Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource. Participants will be randomized to one of two groups. Group one will be usual care and group two will be the Rx synchronization group.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

691Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Refill synch	Experimental	Participants in this group will have their medication refill schedule synchronized.	Behavioral: Refill synch
Control	No Intervention	Participants in this arm will receive usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Refill synch	Behavioral		Refill synch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication adherence to each of the chronic medications as measured by the proportion of days covered (PDC) measure		6 months and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcomes will be continuous gaps (e.g. 15, 30, or 60 days) in medication use.		6 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource.

Exclusion Criteria:

under 18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jalpa Doshi, PhD	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Humana, Inc		Louisville	Kentucky	40202	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D006937	Hypercholesterolemia
D003920	Diabetes Mellitus
D055118	Medication Adherence

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006949	Hyperlipidemias
D050171	Dyslipidemias

Browse Leaves

Not provided

Browse Branches

Not provided